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NCT Number: NCT06557252

The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG

Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Endoscopy center gastroenterologists in our hospital in 2024

Exclusion criteria

Doctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.

Treatment and study plan

PDCA training

Behavioral

Improve diagnostic rate

Primary outcomes

  1. Diagnostic Accuracy of AIG

    Time frame: 4months

    To diagnose Autoimmune Gastritis (AIG), the following two criteria must be simultaneously met:

    Endoscopic or histopathological findings, or both, that are consistent with the characteristics of autoimmune gastritis.

    Positive gastric autoantibody status, including the presence of anti-parietal cell antibodies (PCA) or anti-intrinsic factor antibodies (IFA), or both.

  2. The suspected diagnosis rate of AIG

    Time frame: 4months

    If only the endoscopic or histopathological findings, or both, are consistent with the characteristics of autoimmune gastritis, but the gastric autoantibody status (anti-parietal cell antibodies or anti-intrinsic factor antibodies) is not confirmed to be positive, then the case should be considered as a suspected case of Autoimmune Gastritis (AIG).

Secondary outcomes

  1. Parietal Cell Antibody(PCA)

    Time frame: 4months

    PCA is an important indicator in the diagnosis of AIG.

  2. IF-Ab

    Time frame: 4months

    IFA is an important indicator in the diagnosis of AIG.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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